Problems associated with acute or chronic diseases in cavities or internal anatomical sites in the body, for which it is sometimes necessary to enter via a bone are known in medicine. The sinus maxillaris is an example of a cavity where much too often rhinosinus diseases occur, which require medical and/or surgical treatment. The problem, in these cases, is the passage into the cavity, either for diagnostic purposes, or for topical treatment in situ, as well as medical treatment, or observation and evaluation.
There are known in current medicine certain devices for temporary insertion related to sinus cavities.
Using "SinoJet.TM." from ATOS MEDICAL company, it is possible to insert a silicone rubber tube via the lower meatus. Its insertion is carried out by a special puncturing or driving means, similar to a trigger. Insertion is fast, by pressing on and breaking tissues. Therefor, the only feasible path for this device is the lower meatus. While this tube may be inserted under a certain degree of control, the possibility that it be introduced too deep into the sinus maxillaris, thus causing undesired effects, cannot be ruled out. The tube may be kept in place for a few days as a means to be in contact with the sinus maxillaris in the lower meatus, but it is not designed or intended to be inserted permanently or for long periods of time and it is not sealable. At its forward end, the tube is in the shape of a truncated arrow with a pair of fins on either side, and its rear end is beadless. This tube allows for irrigation or flushing of the sinus maxillaris, but because of its small inner diameter it is impossible to look into the sinus maxillaris, since it does not allow for insertion of any direct vision optical instrument through it.
"Rains Frontal Sinus StentTM", sold by Smith+Nephew ENT, is a silicone rubber device designed solely for temporary insertion into de frontal sinus. Following frontal sinus endoscopic surgery, the tube is inserted exclusively for the purpose of preventing a surgical complication or natural reclosure of the opening in the frontal recess. The tube will maintain a surgical opening cut through the ostrum of the frontal sinus for 7 to 14 dais after surgery. The device has a hollow stem, and at its forward end it is provided with a head or bulb which, upon insertion into the frontal sinus, it keeps the tube within the cavity. While it is supposed to be self-fastening, it does not allow for an accurate control of its advancing or keeping the tube in place within the frontal sinus. This device is not designed for permanent placement, it is not sealable, it cannot be used to inject or remove any solutions from the frontal sinus nor does it allow for insertion of direct viewing optical instruments through its lumen.
"Shikani Middle Meatal Antrostomy Stent (SMMAS).TM." sold by Micromedics, Inc., is designed to be inserted following functional endoscopic surgery of the sinus maxillaris. The above device, SMMAS, is introduced via an antrostomy made in the middle meatus, by means of a Ferris-Smith forceps. The device is kept in place temporarily for 10 to 14 days after surgery, after which it is readily removed via the nasal fossa. It has a sole purpose: preventing adhesions from being formed by adjacent tissues through connection of same between the middle ethmothurbinate and the nasal side wall. The above device is made of a soft material, such as silicone rubber, it has two fins at its forward end which prevent the device from undesirably slipping out of the opening, and at its rear end it has a bead that prevents both the middle ethmothurbinate and the nasal side wall from attaching one another, and the undesirable advance of the device into the cavity of the sinus maxillaris. The device SMMAS is not sealable and its use is intended for a short period of time, with insertion only through the middle meatus.
There are known, in prosthetic and implant medicine devices to be affixed to a bone. These devices generally comprise one or several components, for a reliable attachment of the same to the bone, because prostheses attached to a bone will generally have to bear a heavy load, whether it is a prosthesis or a dental implant, a lockscrew in a limb, an artificial joint or the like. Therefore, it is required a reliable attachment, which provides for an unlimited and more secure use of the prosthesis. The components are substantially solid, and they may be generally attached to a bone by means of threads, since this combination insures a better attachment.
Generally, devices are solid or partially hollow. The latter may be provided with a stopper system, but they cannot provide a passageway through their lumen between two different anatomical sites, for one of their ends is closed.
There are also hollow devices which, after being inserted through a bone, define a passageway between two different anatomical sites, but which lack an internal stopper system, leaving both of the above histic surfaces in permanent open connection.